the efficacy and safety of udenafil in patients with erectile dysfunction after bilateral nerve-sparing radical prostatectomy

Conditions: Prostate Cancer With Radical Prostatectomy

Summary: this study evaluates the efficacy and safety of udenafil dosed once a day in patients with erectile dysfunction after bilateral nerve-sparing radical prostatectomy.


Eligibility criteria:
inclusion criteria: * male aged 20 or over 20 years and not more than 70 years who underwent bilateral nerve-sparing radical prostatectomy due to prostate cancer without metastasis * iief-ef score ≥22 at 1-8 weeks before bilateral nerve-sparing radical prostatectomy, and iief-ef ≤16 at screening visit * presence of sexual partner from 8 weeks before bilateral nerve-sparing radical prostatectomy, and had planned to keep it during the trial * agreed not to use any other erectile dysfunction medication (including both generic and specialty medicines) and other erectile dysfunction therapies during the trial period. * patient agrees to voluntary participation and follow the instructions carefully, after fully hearing and understanding the details of this clinical trial exclusion criteria: * patient who needs additional treatment in addition to bilateral nerve- sparing radical prostatectomy * use inhibitors of pde-5 (viagra®, levitra®, cialis®, zydena®, yaila®, mvix® and generic medicines) or autologous injections of vasodilators or other erectile dysfunction therapies for erectile dysfunction within the first 8 weeks of bilateral nerve-sparing radical prostatectomy * if there is an uncontrolled diabetes (hba1c\> 12%) at visit 1 * if there is proliferative diabetic retinopathy at visit 1 * if there is a history of cabg surgery, stroke, unstable angina, myocardial infarction, life-threatening arrhythmia, or heart failure within 6 months before the screening visit * history of spinal cord injury, non nerve-sparing radical prostatectomy or radical pelvic surgery * hypotension below 90 / 50mmhg or uncontrolled hypertension above 170 / 100mmhg * penis anatomic abnormalities (severe penile fibrosis, peyronie's disease, etc.) * presence of serious disability such as malignant tumor, lung, blood, endocrine system in visit 1 * patient who have active hepatitis b or c or who are infected with hiv virus * patient who have genetic problems such as galactose intolerance, lapp lactose dehydrogenase deficiency, glucose-galactose uptake disorder * patient who have hyperprolactinemia or hypothyroidism * serum ast and alt are three times higher than normal upper limit * serum creatinine ≥ 2.5 mg / dl * patient who have retinitis pigmentosa * patient who have blood disease (sickle cell disease, multiple myeloma, leukemia) or bleeding disorder that can cause priapism * patient with congenital qt prolongation syndrome or those taking a drug that increases qt interval * if the examiner considers that he / she is not suitable for participation in clinical trials, such as mental disorder or persistent abuse of medication * patient who is taking nitrate / nitric oxide (no) donor (nitroglycerin, sodium nitroprusside, isosorbide mononitrate / dinitrate, amyl nitrate / nitrite, etc.) * patient who is taking guanylate cyclase stimulator (such as riociguat) * patient who is taking warfarin * patient who is taking medications or foods that affect cyp3a4 metabolism * metabolic inhibitors: antibacterials (erythromycin, etc.), antifungals (itraconazole, etc.), antivirals (ritonavir, saquinavir, amprenavir, indinavir, nelfinavir, etc.), h2 receptor antagonist (cimetidine, etc), or grapefruit juice * metabolic inducers: dexamethasone, rifampicin, antipyretics (phenytoin, phenobarbital, carbamazepine, etc.) * patient who is taking androgens (testosterone, etc.) or anti-androgens (5α-reductase inhibitors such as finasteride, dutasteride and anti- androgen hormones such as flutamide and bicalutamide) * patient who is taking trazodone * patient who received other clinical trial medications (including placebo) within 4 weeks before the screening visit * history of hypersensitivity reactions to pde-5 inhibitors (viagra®, levitra®, cialis®, zydena®, yaila®, mvix® and each generic drug) * patient who did not respond to pde-5 inhibitors (viagra®, levitra®, cialis®, zydena®, yaila®, mvix® and each generic drug) * patient who has hypoactive sexual desire * if the examiner judges that it is not suitable for participation in this trial